BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 3200961 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-04009
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 3, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING A SCREW THAT PENETRATED THE PLATE DURING A PROCEDURE TO TREAT A DISTAL RADIUS FRACTURE. AFTER THE SURGEON INSERTED ALL THE SCREWS, 4 IN TOTAL, THE SURGEON ATTEMPTED TO TIGHTEN THEM, USING THE TORQUE-LIMITER. THE SCREW IN THE PROXIMAL ROW, MOST STYLOID, WENT THROUGH THE BONE. THIS IS REPORT NUMBER 2 OF 2 FOR COMPLAINT REPORT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303528 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN HWC SYNTHES (USA) 8316983

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR